Kornimate/medical-research-clean huggingface dataset:
burst spinal cord stimulation for neuropathic pain.

Conditions: Peripheral Neuropathic Pain; Radiculopathy; Lower Back Pain

Summary: this study will evaluate the effect of burst spinal cord stimulation (scs) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. it is a multicenter double-blinded "n-of-1" rct with repeated two-week periods of burst scs or sham in randomised order.

scs is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. the analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms. traditional "tonic" scs causes paresthesia during treatment, but the newer burst technique (five electrical pulses at 500hz delivered in intermittent packets of 40 hz) can be performed below detection level. thus, it is possible to do double-blinded sham-controlled studies. in this study, we will study the effect of burst scs compared with sham on pain intensity and function (patient-specific functional scale). in addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).

Eligibility criteria:
inclusion criteria: * history, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. the pain in the extremity(ies) must dominate. * understand norwegian or swedish language (written and spoken). * usual pain intensity ≥ 3.5 / 10 (nrs 0-10) exclusion criteria: absolute * opioid dose \> 100 mg morphine equivalents / day * ongoing litigation * mental / psychiatric disorder that may affect treatment * chronic generalized pain * pregnancy * hypersensitivity to local anesthetics * serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders * laminectomy in or above level for planned epidural access * spine surgery the last 3 months relative * ongoing medication that affects coagulation or platelet function
study on the effect of kaletra + nevirapine as maintenance bitherapy compared to a triple therapy including kaletra + analogues in hiv patients

Conditions: HIV Infections

Summary: the study aims to evaluate the changes in mitochondrial dna (mdna) by means of the mdna/nucleardna (ndna) ratio as a marker of mitochondrial toxicity following the interruption of nucleoside analogues.

at the moment it is known that mitochondrial toxicity is the main pathogenic mechanism of toxicity associated with nucleoside analogues, including lipoatrophy, which at facial level is a stigmatising factor for patients with hiv infection. the primary outcome measure of the design of an "ntri-sparing" bitherapy is to retard the onset of mitochondrial toxicity or reverse it, mainly with regard to the loss of subcutaneous fat or lipoatrophy. lopinavir/ritonavir and nevirapine are two antiretrovirals with different mutation patterns and with high antiviral potency. their combination therefore guarantees antiviral success. the neka study endorses efficacy immunologically and virologically (negredo e. et al, nrti-sparing regimen. xiv international aids conference. barcelona 2002. lb peb9021). similarly, the protective effect of nevirapine on lipid metabolism would counteract the negative impact attributed to lopinavir/ritonavir, reducing cardiovascular risk in these patients.

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years. 2. hiv-1 infected patients. 3. patients on haart therapy with pis or nnrtis. 4. patients with an undetectable viral load (\<50/80 copies/ml) over the last 6 months (at least 2 determinations separated by 2 months). 5. hepatic tests \< 5 times the normal value. 6. subject able to follow the treatment period. 7. women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study. 8. signature of the informed consent exclusion criteria: 1. presence of opportunistic infections and/or recent tumours (\< 6 months). 2. suspicion of resistance or documented resistance to any of the investigational drugs. 3. suspicion of possible bad adherence. 4. pregnancy or breastfeeding; refusal to follow reliable contraception over the treatment period. 5. known allergic hypersensitivity to any of the investigational drugs or any similar drug. 6. patients participating in another clinical trial.

Keywords: mitochondrial toxicity lopinavir-rtv nevirapine dna mitochondrial/dna nuclear
open hemorrohoidectomy vs transanal hemorrhoidal desarterialization in hemorrhoids grade iii: the effect on symptoms

Conditions: Hemorrhoids Third Degree

Summary: the goal of this clinical trial is to learn if open hemorroidectomy diminishes symptoms compared to transanal hemorrhoidal desarterialization (thd) in patients presenting with hemorrhoids grade iii. the main question it aims to answer is: - do patients undergoing open hemorroidectomy present with lesser symptoms 1 year after surgery, compared to those undergoing a thd? researchers will compare open hemorroidectomy to thd in terms of symptom response one year after the procedure. participants will: * undergo surgical treatment of hemorroids performed by one of the two techniques: open hemorroidectomy versus thd. * fill in symptom forms before and one year after the surgical procedure. * attend control visits one week, one month, three months and one year after the surgical procedure.


Eligibility criteria:
inclusion criteria: * age older than 18. * hemorroids grade iii. * surgical indication for hemorroid treatment. * signed informed consent. exclusion criteria: * acute hemorroidal disease. * previous hemorroidal surgery. * concomitant anal fissure. * concomitant perianal fistulae. * concomitant rectal prolapse. * inflamatory bowel disease. * anal or colorrectal cancer.

Keywords: hemorrhoids third degree botulinum toxin hemorrhoidectomy transanal hemorrhoidal dearterialization hemorrhoidal disease symptom score
role of coenzyme q in adhd in children

Conditions: ADHD

Summary: role of coenzyme q in adhd in children

role of coenzyme q in adhd in children: will it add a benefit?

Eligibility criteria:
inclusion criteria: * patients with adhd exclusion criteria: * comorbidities like autism, anxiety, obsessive compulsive disorder.
bemer in the treatment of pain in fibromyalgia.

Conditions: Fibromyalgia

Summary: fibromyalgia is one the most common causes of chronic pain syndromes in women. it causes considerable costs in primary health care setting as well as specialized medical care sector.electrotherapy and exercise therapy has shown to have short-term pain relieving effects in randomized controlled trials (rct) among fibromyalgia patients. however, there is sparse knowledge about the effects of long-term rcts in the treatment of pain in fibromyalgia, as there are no publications about cost-effectiveness analysis of such treatments. the aim of this study is to investigate whether the bemer electromagnetic field therapy device has beneficial long-term effects in the treatment of pain, and whether it improves fibromyalgia patients' quality of life. in addition, this study investigates whether the bemer device treatment is cost-effective in the treatment of fibromyalgia patients.

the participants of this study are working age female patients from the central finland health care district, and who have been treating because of severe pain. after eligibility has been assessed by health-related questionnaire and clinical examination, the participants will be randomly assigned into the treatment or control group. treatment group patients will receive the loan activated bemer-care unit, while controls will receive inactivated sham bemer-unit. all participants will use the device regularly on a daily bases over three months. after one month treatment break, the treatment group will become a control group and control group will become a treatment group according cross-over design principle. switching the groups will take place by changing the bemer devices during the break. throughout the study, both participants and researchers are unaware whether the participants are using activated or inactivated bemer-devices. the research will be carried out and coordinated by central finland central hospital, and the research project will take place between september 2014 and june 2018.

Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia * chronic persistent moderate or severe pain for more than 12 months * average minimum pain intensity of 5 in the scale of 0 to 10 during the last 7 days * age between 18 and 60 years * female gender exclusion criteria: * an inflammatory rheumatic disease * some other chronic pain disease as fibromyalgia * psychiatric illness * addiction to opiates * substance abuse * smoking * a person with disability * pregnancy and breast-feeding

Keywords: fibromyalgia electromagnetic field therapy randomized controlled trial
expiratory muscle function in critically ill ventilated patients

Conditions: Mechanical Ventilation; Expiratory Muscle; Critical Illness; Muscle Atrophy or Weakness; Diaphragm

Summary: inspiratory muscle weakness develops rapidly in ventilated critically ill patients and is associated with adverse outcome, including prolonged duration of mechanical ventilation and mortality. surprisingly, the effects of critical illness on expiratory muscle function have not been studied. the main expiratory muscles are the abdominal wall muscles, including the external oblique (eo), internal oblique (io) and transversus abdominis muscles (tra). these muscles are activated when respiratory drive or load increases, which can be during e.g. exercise, diaphragm fatigue, increased airway resistance, or positive airway pressure ventilation. the abdominal wall muscles are also critical for protective reflexes, such as coughing. reduced abdominal muscles strength may lead to decreased cough function and thus inadequate airway clearance. this will lead to secretion pooling in the lower airways, atelectasis, and ventilator associated pneumonia (vap). studies have shown that decreased cough function is a risk for weaning failure and (re)hospitalization for respiratory complications. further, high mortality was found in patients with low peak expiratory flow. considering the importance of a proper expiratory muscle function in critically ill patients, it is surprising that the prevalence, causes, and functional impact of changes in expiratory abdominal muscles thickness during mechanical ventilation (mv) for critically ill patients are still unknown. ultrasound is increasingly used in the icu for the visualization of respiratory muscles. in a recent pilot study the investigators confirmed the feasibility and reliability of using of ultrasound to evaluate both diaphragm and expiratory abdominal muscle thickness in ventilated critically ill patients (manuscript in preparation). accordingly, the primary aim of the present study is to evaluate the evolution of abdominal expiratory muscle thickness during mv in adult critically ill patients, using ultrasound data.


Eligibility criteria:
inclusion criteria: * age \> 18 years * invasive mechanical ventilation \< 48 hours * expected duration of mechanical ventilation \> 72 hours exclusion criteria: * past medical history of neuromuscular disorders * mechanical ventilation \> 48 hours within the current hospital admission * pregnant women * open abdominal wounds at proposed location of the ultrasound probe, due to recent abdominal surgery
effects of endotoxin absorption and cytokine removal hemofilter on severe septic shock

Conditions: Sepsis, Severe; Septic Shock

Summary: in recent years, many studies have pointed out that bacterial toxin and cytokine storm are the main causes of shock and multiple organ failure in patients with sepsis. endotoxin is the main vehicle for systemic inflammatory reaction caused by gram-negative bacteria which induce sepsis. endotoxin binds to toll- like receptor 4 (tlr4) trigger a cytokine storm. the amount of endotoxin is associated with shock, insufficient intestinal perfusion, and poor prognosis. therefore, clinicians try to use various methods to antagonize the action of endotoxin, which can reduce the cytokine storm and inflammatory response to improve the prognosis of sepsis. continuous venous venous hemofiltration plays a role in blood purification in septic shock. with different hemofiltration filters, it has different effects. by removing the inflammatory mediators caused by bacterial toxins and cytokines, shock can be improved. the study plans to receive patients with septic shock and use a hemofiltration filter that adsorbs endotoxin and removes cytokines (oxiris, baxter healthcare) to perform continuous venous venous hemofiltration in addition to basic septic shock resuscitation. the effect on the concentration of cytokines in the blood, the infusion dose of inotropics, the fluid balances, and the degree of organ damage was evaluated. it is hoped that the results of this pilot study can lead us to subsequent randomized clinical trials to explore whether this filter can improve the prognosis of septic shock patients.


Eligibility criteria:
inclusion criteria: * patients who meet all criteria (a+b+c): * a) identified infection source under adequate treatment * b) sepsis (the sequential organ failure assessment score rise 2 points or more) * c) severe septic shock (serum lactate \> 2 mmol/l; need continuous norepinephrine infusion to maintain adequate blood pressure, of which dosage is \> 0.2 mcg/kg/min for more than 1 hour or \>0.1 mcg/kg/min for more than 3 hours ) exclusion criteria: * onset of severe septic shock more than 24 hours * received continuous renal replacement therapy within 24 hours before enrollment * serum white blood cell count count \< 1000 cells/μl or platelet count \< 50000 cells/μl * history of allergy to heparin * received cardiopulmonary resuscitation within 4 weeks before enrollment * icu admission due to severe septic shock within 2 months * patients or family had chosen palliative care and signed an agreement to deny aggressive treatment * pregnancy * apache ii score \> 30 at enrollment * non-native speakers

Keywords: critical care septic shock hemofiltration endotoxin cytokine storm prognosis
evaluation of the effects of routine intake of fresh vs- pasteurized yoghurt on the immune system in healthy adults

Conditions: Immune System; Innate Inflammatory Response

Summary: in this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. a unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. a complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed.


Eligibility criteria:
inclusion criteria * age between 20 and 70 years, both included. * healthy or mildly ill subjects (without any current chronic pharmacotherapy). * body mass index between 18.5 and 29.9 kg/m2, both included. * subjects who usually follow a balanced diet that are not engaged in any therapeutic lifestyle change involving stringent dietary interventions such as weight-reducing diets. * written informed consent to participate exclusion criteria * patients could not meet any the following criteria at the screening visit to be included in the study. * subjects with diseases or disorders affecting the function of the immune system, such as auto-immune diseases, allergies, atopic conditions, hypersensitivity to any kind of stimulus, or immunosupression for any reason; even if they are not currently taken any pharmacotherapy. * subjects with relevant functional or structural disorder affecting the gastrointestinal tract, such as malformations, angiodysplasias, active peptic ulcers or chronic inflammatory disease of the intestine; even if they are not in any specific pharmacotherapy at the time of recruitment; or who have underwent surgical procedures with permanent sequels (for example, gastroenterostomy). * subjects with any infectious disease requiring antibiotherapy at the time of recruitment. * subjects following any treatment modifying the immune response, such as immunosuppressants, corticosteroids, etc. * subjects with celiac disease. * subjects with chronic background weakening conditions, such as diabetes or neoplasms. * subjects with history of renal lithiasis. * subjects with deficient nutritional or hydrational status. * subjects with relevant deviations in routine haematology or biochemistry parameters. * subjects with current and documented alcohol abuse. * subjects in whom the investigator expected insufficient collaboration or difficulties to follow the study procedures. * subjects who regularly took any of the forbidden products specified in the appropriate section.
xelox in advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy

Conditions: Biliary Tract Cancer

Summary: phase ii study of second line capecitabine plus oxaliplatin (xelox) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.

xelox * xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks * oxaliplatin 130mg/㎡, day 1, every 3 weeks until disease progression, patient's refusal or up to 8 cycles (maximum).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of vater cancer) 3. unresectable or metastatic 4. progression after treatment with first line gemcitabine-based chemotherapy 5. ecog performance status of 0\~2 6. measurable or evaluable lesion per recist 1.1 criteria 7. adequate marrow, hepatic, renal and cardiac functions exclusion criteria: 1. severe co-morbid illness or active infections 2. pregnant or lactating women 3. history of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ecg, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia 4. active cns metastases not controllable with radiotherapy or corticosteroids 5. known history of hypersensitivity to study drugs
an observational study of xeloda (capecitabine) in participants with metastatic or advanced breast cancer

Conditions: Breast Cancer

Summary: this observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (xeloda®) in participants with metastatic or advanced breast cancer. eligible participants will be followed for up to 24 months.


Eligibility criteria:
inclusion criteria: * adult female participants, \>/= 18 years of age * cytologic/histopathologic confirmed diagnosis of metastatic breast cancer * prescribed capecitabine as in routine clinical practice * informed consent signed exclusion criteria: * participation in any other clinical trial * history of severe and unexpected reactions to fluoropyrimidine therapy * hypersensitivity to capecitabine or to any of the excipients of fluorouracil * known dihydropyrimidine dehydrogenase (dpd) deficiency * pregnant or lactating women * severe leucopenia, neutropenia, or thrombocytopenia * severe hepatic impairment * severe renal impairment (creatinine clearance below 30 ml/min) * treatment with sorivudine or its chemically related analogues, such as brivudine * refusal to give consent
locally delivered doxycycline adjunct to nonsurgical periodontal therapy.

Conditions: Periodontal Disease

Summary: the aim of this clinical study is to asses the effect of ultrasonic periodontal debridement associated to locally delivered doxycycline (20%) by plga microspheres on chronic generalized periodontitis treatment.

thirty patients with chronic periodontitis and a minimum of seven pockets (\>5 mm) in non-molars teeth that bled on probing will be selected. patients will be randomly assigned to ultrasonic periodontal debridement followed by local application of doxycycline by plga microspheres (db+dox) and periodontal debridement followed by administration of void plga microspheres (db). plaque, bleeding on probe, clinical attachment level (cal), and probing depth (pd) will be recorded at baseline, 3 and 6 months. subgingival biofilm samples will be collected from initially moderate (5 to 6 mm) and deep (≥7 mm) pockets at baseline, 1, 3 and 6 months. polimerase chain reaction (pcr) analysis will be used to detect the frequency of porphyromonas gingivalis (pg), tannerella forsythia (tf), treponema denticola (td), aggregatibacter actinomycetemcomitans (aa), and prevotella intermedia (pi).

Eligibility criteria:
inclusion criteria: * chronic generalized periodontitis (aap,1999); * at least 7 sites with probing depths \>5mm, and 2 sites with probing depth \>7mm; * at least 20 teeth present; * systemically healthy. exclusion criteria: * had received periodontal care 6 months prior to the study; * had taken medications known to interfere with periodontal health and healing 6 months prior to the study; * pregnants or lactants; * smokers; * sensitive to doxycycline.

Keywords: chronic periodontitis local doxycycline ultrasonic debridement plga microspheres microbiologic assessment
study of postoperative delirium in elderly people after orthopedic surgery

Conditions: Postoperative Delirium

Summary: the purpose of this study is to investigate the possible relationship of microrna and postoperative delirium.

postoperative delirium is one of the most common postoperative complications in elderly patients.it has been shown that postoperative delirium has independent adverse effects on short and long-term mortality and morbidity, including poor functional recovery, postoperative cognitive dysfunction, deterioration in quality of life, and increased costs. however, at the present time, postoperative delirium is a clinical phenomenon, and its neuropathogenesis remains unknown. this gap in knowledge has become a barrier that limits further studies, including the development of potential interventions for postoperative delirium.

Eligibility criteria:
inclusion criteria: 1. 65 years old or older 2. candidates for spinal anesthesia 3. non language communication barriers exclusion criteria: 1. past medical history of neurological and psychiatric diseases including ad, other forms of dementia, stroke, or psychosis; 2. severe visual or hearing impairment; 3. unwillingness to comply with the protocol or procedures.

Keywords: postoperative delirium microrna
fibromyalgia sleep a to zzz study

Conditions: Fibromyalgia

Summary: this research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.

this study will test a consumer health light therapy device (re-timer)

Eligibility criteria:
inclusion criteria: 1. meets 2016 revised diagnostic criteria for fibromyalgia (fm) 2. has access to video conferencing (including web cameras and audio) and a private space for the remote study visits. exclusion criteria: 1. significant chronic disease 2. severe hearing or memory problems 3. pending medical leave applications at workplace 4. current pregnancy, breastfeeding, or actively trying to get pregnant 5. night work or travel outside the eastern time zone within 1 month of the study 6. other research participation 7. frequent number of special events during study period (weddings, concerts, exams, etc).

Keywords: sleep timing stabilization morning light therapy